Skip to main content
OpenTrials
Completed

NCT Number: NCT01937559

Topical Tranexamic Acid (TXA) in Joint Arthroplasty

The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Hip Arthropathy Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Shoulder Arthropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Greenville, South Carolina, 29615, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Shoulders: All adult patients over the age of 18 scheduled for a primary total arthroplasty or a primary reverse shoulder arthroplasty will be eligible for inclusion in the study.

Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for inclusion in the study.

Exclusion criteria

  • allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance <30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin <11g/dl in females and < 12g/dl in males).

Treatment and study plan

Tranexamic acid (TXA)

Biological

1.5g of TXA in 100ml normal saline solution

Other names: Cyklokapron

normal saline

Drug

Primary outcomes

  1. Post-operative Blood Loss

    Time frame: Duration of hospital stay, up to 4 days

    Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.

Secondary outcomes

  1. Number of Participants With Perioperative Blood Transfusions

    Time frame: Duration of hospital stay, up to 4 days

  2. Number of Blood Units Transfused

    Time frame: Duration of hospital stay, up to 4 days

  3. Rate of Surgical Infections

    Time frame: Duration of hospital stay, up to 4 days

  4. Length of Hospital Stay

    Time frame: Duration of hospital stay

  5. Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).

    Time frame: 6 months post-surgery

    • Single Assessment Numeric Evaluation (SANE): A single question that asks "How would you rate your hip today as a percentage of normal (0% to 100% scale with 100% being normal)?" 0 indicates an abnormal shoulder, whereas 100% indicates a perfectly normal shoulder.
    • Euroqol-5D (EQ-5D): The EQ-5D is a patient-reported overall health questionnaire, with 100 indicating "The best health you can imagine" and 0 indicating "The worst health you can imagine."
    • Global Rating of Change Scale (GRoC): Provide a means of measuring self-perceived change in health status. The main purpose is to quantify the extent to which a patient has improved or deteriorated over time. The outcome is measured on a scale of -7 to 7, with -7 being the hip is "a very great deal worse from before surgery" and 7 being the hip is "a very great deal better from before surgery."

  6. Patient-reported Outcome Scores Including the Harris Hip Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: 6 months after surgery

    Harris Hip Score: Consists of 10 question items evaluating pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes, whereas lower scores represent more dysfunction and worse outcomes.

    Western Ontario and McMaster Universities Arthritis Index (WOMAC): Consists of 24 questions evaluating hip pain, stiffness and function. The score is normalized to a 100 point scale, where 0 indicates a poor outcome and 100 indicates the best outcome.

Sponsors and collaborators

Lead sponsor

The Hawkins Foundation

Other

Registry information

Official study title

Topical Application of Tranexamic Acid in Joint Arthroplasty

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2013
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.